The combination regimen was approved for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer with specific EGFR mutations.
RT’s Three Key Takeaways:
- FDA Approval for NSCLC Treatment: The FDA has approved the combination of Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations.
- Study Shows Improved Outcomes: In the phase 3 MARIPOSA study, the Rybrevant and Lazcluze combination reduced the risk of disease progression or death by 30% compared to osimertinib, with a median progression-free survival of 23.7 months.
- New Treatment Option: The approval introduces a new chemotherapy-free treatment option for patients with advanced EGFR-mutated NSCLC, with the combination demonstrating a longer median duration of response and a consistent safety profile.
Johnson & Johnson announced that the US Food and Drug Administration (FDA) approved Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
With this approval, Rybrevant plus Lazcluze becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC.
Rybrevant is an EGFR- and MET-directed bispecific antibody that engages the immune system, and Lazcluze is a highly selective, brain-penetrant, third-generation oral EGFR TKI. Rybrevant plus Lazcluze is the only multitargeted regimen targeting both the common EGFR mutations directly.
Lung cancer is the leading cause of cancer mortality worldwide, resulting in 1.8 million deaths each year, with NSCLC accounting for 80-85% percent of all cases. Of patients with EGFR-mutated NSCLC, between 25-39% never receive second-line therapy, due to disease progression and lack of treatment options.
The five-year survival rate is less than 20% for all people with advanced EGFR-mutated NSCLC treated with current standard of care TKI monotherapy. Acquired resistance mechanisms after TKI monotherapy make subsequent treatment more difficult.
Approval Based on Phase 3 MARIPOSA Study
The FDA approval is based on positive results from the phase 3 MARIPOSA study, which showed Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% percent compared to osimertinib (median progression-free survival: 23.7 months versus 16.6 months) in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
The median duration of response was nine months longer with Rybrevant plus Lazcluze versus osimertinib (25.8 months versus 16.7 months), a secondary endpoint of the study.
“Building on more than three decades of oncology innovation, we are uniquely positioned to build best-in-class treatments where survival rates have remained stagnant for years,” says Jennifer Taubert, executive vice president, worldwide chairman, innovative medicine, Johnson & Johnson, in a release. “Rybrevant plus Lazcluze establishes a new benchmark in the advanced first-line setting, and we look forward to bringing this new chemotherapy-free treatment regimen to patients.”
The safety profile of Rybrevant plus Lazcluze was consistent with the profiles of the individual treatments. Venous thromboembolic events were observed with the combination. Adverse event rates were consistent in this arm as compared to other Rybrevant regimens.
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